2. Proposed Guidelines are CPTPP-plus

NPRA has proposed guidelines on implementation of patent linkage on the basis that this is a requirement under Article 18.53 of the CPTPP. But the CPTPP does not explicitly mention patent linkage (PL). In any case, PL is a TRIPS-plus measure and there is no one-size-fits-all approach to implementing PL even if a country decides to do it.

Article 18.53 of CPTPP provides two options for implementation. Of the two options, Article 18.53.2 is the worse option for access to medicines. There is no need to implement that option. The minimum required by Article 18.53.1 is a notification system and availability of judicial remedies.

NPRA has ignored this fact. Instead, NPRA’s proposed Guidelines suggests establishing 4 categories, requiring PRH NDP (i.e. the originator) and the PRH generic applicants to provide a list of patents and pending patents, imposing a 45-day notification period during which NPRA withholds registration decisions, and providing for an automatic 12-month suspension of the regulatory approval process if the patent holder initiates legal action. Further, the Guidelines proposes an expansive scope that includes secondary patents that will merely encourage “evergreening” of patents in Malaysia. None of these elements are required under the CPTPP. Notably, New Zealand and the United Kingdom—both CPTPP parties— with Gross National Income per capita 4 times larger than Malaysia have made clear that compliance with Article 18.53 of CPTPP does not necessitate such measures.

In particular, the 45-day notification period followed by an automatic 12-month suspension is unjustified and unnecessary. Section 60 of the Malaysian Patents Act 1983 (amended 2022) recognizes the possibility of the patent holder to apply for an injunction including for situations when the patent holder can prove imminent infringement. Such remedies are provided by Malaysia’s judicial system and can be obtained rapidly within 48 hours. There is no need for NPRA to do anything. CPTPP also only requires notice to be provided to the patent holder. But the proposed Guidelines require category 4 applicants to provide 2 notices, one to the patent owner or patent licensee and another to the product registration holder of the NDP.

The proposed Guidelines also extend to “For Export Only (FEO) products” which is not required by the CPTPP. The title of Article 18.53 of CPTPP is “Measures relating to the marketing of certain pharmaceutical products” and the sub-paragraphs are about marketing of the pharmaceutical product. In the case of FEO products, there is no marketing in Malaysia. Moreover, patents are territorial in nature, meaning that even if a pharmaceutical product may have some patents (valid or weak patents) in Malaysia, the same product may not have any patents in the country to which the product is exported. There is thus no legal basis for applying the proposed Guidelines to FEO products.

Against the above background, it is evident that NPRA’s proposal goes far beyond what is minimally required to implement Article 18.53 of CPTPP and risks serious negative consequences for generic competition and access to affordable pharmaceutical products in Malaysia.

We emphasise that any implementation of Article 18.53 of the CPTPP should be confined strictly to what is required under Article 18.53.1. In practice, this would only necessitate NPRA providing a simple public notice—such as publishing, on its website, information that a marketing approval application has been filed, shortly before approval is granted. Malaysian law already provides the necessary legal remedies under the Patents Act and the Rules of Court, and no additional regulatory measures are required to implement Article 18.53 CPTPP.